Breast shield

Abstract

A breast pump (10) for expressing human breast milk. The breast pump (10) includes an outer shell (12) and a flexible inner liner (14) located within the outer shell (12). In use, when the breast pump (10) is applied to the breast, the inner liner (14) contacts the surfaces of both the areola and the nipple of the breast. The breast pump also includes an outer chamber (20) located between the outer shell (12) and the inner liner (14) and an inner chamber (18) located within the inner liner (14). In use, the inner chamber (18) and the outer chamber (20) are able to withstand a pressure difference that can be operated to cause the inner liner (14) to exert a massaging effect on the surfaces of both the areola and the nipple of the breast.

Description

[0001] Cross-references of priority

[0002] This application claims priority to Australian Provisional Patent Application No. 2020900501, filed on 21 February 2020, and Australian Provisional Patent Application No. 2020902945, filed on 18 August 2020, the contents and disclosures of which are incorporated herein by reference. Technical Field

[0003] The present invention relates to a breast shield for use in a mechanical breast pump for expressing human breast milk from a lactating mother. Background Technology

[0004] The following discussion of the background of the invention is intended to facilitate an understanding of the invention. However, it should be understood that this discussion is not an endorsement or admission that any aspect of it was part of common general knowledge at the priority date of this application.

[0005] Breast pumps are known in the prior art and include a manual operating unit and a motor drive unit. The motor drive unit can be connected to a mains power source or can be battery-operated. The motor drive unit includes a vacuum pump and one or two breast shields for placement on one or more of the mother's breasts. Breast pumps are intended to mimic the way an infant suckles the mother's breast as closely as possible. The closer the breast pump is to this simulation, the more likely it is to draw milk from the mother's breasts, and the more comfortably the mother can express her breast milk. Therefore, breast pumps are typically developed to use a vacuum to pump in a cyclical manner to apply pressure to the breast and nipple through the breast shields and to release pressure from the breast and nipple, and to create a vacuum within the breast shields or each breast shield to draw milk from the mother's breasts.

[0006] Breast pump components are offered in a wide variety of shapes and forms, designed to ensure a comfortable fit on breasts and nipples of different sizes and shapes. Generally, breast pumps have a round, funnel-shaped opening large enough to receive the nipple and press against the breast around it for a seal. Some breast pumps consist of a single shield into which the nipple is inserted and which seals against the breast skin around the nipple, applying a circulating vacuum within the shield to allow the nipple to elongate and relax, thus drawing breast milk from the breast. Other breast pumps have both a rigid or stiff outer liner or shell (sometimes referred to as the outer "shield") and a flexible inner liner located within the outer liner. In some of these breast pumps, a substantially constant vacuum is applied within the inner liner while a circulating vacuum is applied between the inner and outer liner, whereas in others, the vacuum applied within the inner liner is not constant. The constant vacuum within the liner draws breast milk from the mother's breast, while the circulating vacuum applied between the inner and outer liner causes the liner to apply pressure to the nipple (squeeze the nipple) and release it in a manner considered to better mimic the way an infant suckles at the mother's breast. This squeezing and releasing of the nipple is believed to promote good milk flow through the nipple and reduce the tendency for milk duct blockage and edema, resulting in a good level of comfort for the mother. These are highly beneficial outcomes.

[0007] A major obstacle to successful milk expression lies in the initial initiation of expression (often referred to as "letting out") and the continued expression after letting out. The sensation of pumping is similar to that of a baby suckling, and the comfort experienced by the mother during pumping is a crucial factor in the successful expression of breast milk across multiple pumping sessions. Improving maternal comfort has particularly beneficial effects: mothers are more likely to successfully express breast milk and therefore continue expressing it for an extended period after birth to benefit the newborn, rather than reverting to formula feeding.

[0008] U.S. Patent No. 7,166,087, a patent held by a related corporate entity of the applicant, relates to breast pumps and discloses arrangements for delivering positive or negative pressure to a breast shield, which can be applied individually to different degrees and / or areas of the breast shield to provide an improved simulation of an infant's natural sucking motion. US 7,166,087 also discloses that the breast shield can be constructed in a manner that massages the nipples and breasts of a lactating mother and can apply pressure in a manner that massages the nipples and breasts of a lactating mother. Some of the arrangements disclosed in US 7,166,087 include the use of ribs or protrusions in the breast shield for massage purposes. Ribs or protrusions may be permanently formed in a surface portion of the breast shield that contacts the skin surface of the breast and nipple, or ribs or protrusions may be portions formed due to pressure delivered to the breast shield. That is, ribs or protrusions may be transitional in nature, thus expanding and contracting based on the pressure delivered to the breast shield. Other arrangements disclosed in US 7,166,087 include a single wall-suction breast shield that pulsates in a manner that massages the breasts and nipples, and an inner lining arrangement and an outer lining arrangement in which a chamber is formed between the linings and positive pressure is used to cyclically expand the chamber to press or squeeze the breasts and nipples to massage the breasts and nipples.

[0009] Australian patent application 2016421331 discloses a breast shield designed to stimulate the nipples of the breasts through massage. The breast shield disclosed in application 2016421331 can engage with the breast tissue around the nipple, but there is no instruction to actually massage the breast tissue.

[0010] The present invention aims to provide a breast shield that provides mothers with an improved level of comfort during milk expression, or that provides benefits in achieving milk release and continuing to express milk after release, or that provides an alternative to existing breast shields to offer consumers a better choice. Summary of the Invention

[0011] Therefore, the present invention uniquely provides a breast shield that can be operated to massage both the nipple and areola during human breast milk expression.

[0012] The present invention provides a breast pump for expressing human breast milk, wherein the breast pump includes an outer shell and a flexible inner liner located within the outer shell, wherein, in use, when the breast pump is applied to the breast, the inner liner contacts the surfaces of both the areola and the nipple of the breast, the breast pump also includes an outer chamber located between the outer shell and the inner liner and an inner chamber located within the inner liner, wherein, in use, the inner chamber and the outer chamber can withstand a pressure difference and the pressure difference can be operated to cause the inner liner to apply a massaging effect to the surfaces of both the areola and the nipple of the breast.

[0013] In the above-described forms of the invention, the breast shield may have an inlet end that, in use, abuts against the surface of the areola of the breast and applies a massage effect to the areola. The construction of a breast shield for generating a massage effect at the areola may include both an outer shell and an inner liner, both extending to the inlet end, and an outer chamber extending between the inner liner and the outer shell at the inlet end.

[0014] In a more specific form of the invention, a breast shield for expressing human breast milk is provided, the breast shield comprising:

[0015] A rigid outer shell and a flexible inner liner located within the outer shell.

[0016] The liner defines an inner chamber for receiving the nipple of a human breast, and the annular outer chamber is defined between the outer shell and the liner. The inner and outer chambers are capable of withstanding pressure differentials.

[0017] The breast shield has an inlet end that, during use, abuts against the surface support of the areola of the breast. The outer shell and inner liner extend to the inlet end, such that, during use, the inner liner abuts against the surface support of the areola around the nipple.

[0018] The liner has a compression section located inside the inlet end for receiving the nipple.

[0019] In use, the pressure difference between the inner and outer chambers can be used to: move the inner liner relative to the outer shell at the inlet end to massage the surface of the areola, and to expand and contract the compression section of the inner liner relative to the inserted nipple to massage the surface of the nipple.

[0020] Therefore, the present invention can provide a breast shield that can be operated to massage both the nipple and areola by applying the pressure difference between the inner and outer chambers.

[0021] The present invention also provides a method for operating a breast pump unit for expressing human breast milk using the breast pump shield described above, the method comprising applying a substantially constant vacuum pressure P1 to the inner chamber, and subsequently adjusting the vacuum pressure in the outer chamber such that the operating vacuum pressure P in the outer chamber is adjusted. o Regarding the oscillation of the vacuum pressure P1 in the inner chamber, it causes:

[0022] a. The compression section of the liner expands and contracts relative to the nipple inserted into the compression section to provide a massaging effect on the side surface of the nipple, and

[0023] b. The lining moves relative to the outer shell at the entrance end to create a massaging effect on the surface of the areola.

[0024] The breast pump according to the invention specifically targets both the nipple and areola areas of the breast for massage. This arrangement was developed following research conducted by the applicant and its affiliates, along with other research institutions and personnel employed by the applicant and its affiliates, which showed that initial milk expression (dispensing) can be aided by massaging the areola area of ​​the breast. The research also indicated benefits from continued massage of the areola area and the nipple, as this helps to continue milk expression after dispensing. A primary benefit is that the amount of milk expressed is at a level that allows for the expression of a large quantity of breast milk within an acceptable timeframe. In other words, the research suggests that continued massage of the areola area after the initiation of milk expression has a positive effect on maximizing the amount of milk expressed during pumping and minimizing the time required to achieve that amount. This provides improved convenience and satisfaction for breastfeeding mothers and also offers psychological benefits, as the newborn breastfeeding stage is often quite stressful for mothers, and poor pumping results can exacerbate this stress. Unable to successfully express breast milk may lead a mother to start using formula, and if a mother wants to continue breastfeeding for the health of her infant but is unable to successfully express breast milk through the pumping process, this can have negative mental health consequences.

[0025] Another benefit is that the pumping action of the breast shield according to the invention has been determined to be very comfortable for the mother, and therefore this also promotes the possibility that the mother can continue to express breast milk for a long time during a single pumping session and during a longer period of time in the early stages of the infant's or toddler's life.

[0026] It is noteworthy that while US 7,166,087 mentions the described arrangement for massaging the breasts and / or nipples to improve milk expression, the disclosure of US 7,166,087 does not recognize the benefit of specifically massaging the areolar area of ​​the breast. US 7,166,087 discloses massaging the breasts and nipples to promote milk expression, but does not describe how breast massage improves milk expression or the type of massage used to achieve this purpose. Similarly, application 2016421331 discloses the engagement of breast tissue around the nipple, but does not teach the actual massage of breast tissue, particularly the areolar area around the nipple.

[0027] The aforementioned research, conducted since the priority date of US 7,166,087, led to the development of new breast shield configurations, which are the subject of this application. These new breast shield configurations are specifically designed to massage both the nipple and areola areas in a manner intended to aid in initiating and continuing milk expression. Surprisingly, it has been found that massaging the areola area is as beneficial as massaging the nipple in reducing the tendency for blocked milk ducts and edema to form in the areola area, and more closely mimics the sucking motion of a young child.

[0028] The inlet end of the breast shield may have a generally conical or funnel-shaped portion. This generally conical or funnel-shaped portion may include complementary funnel-shaped portions of the liner and the outer shell, whereby the funnel-shaped portion of the liner serves as a surface-supporting engagement against the areola. The outer chamber may also extend to the inlet end located between the funnel-shaped portion of the liner and the outer shell, such that a pressure difference applied to the inner and outer chambers causes the funnel-shaped portion of the liner to move relative to the funnel-shaped portion of the outer shell. Therefore, the funnel-shaped portion of the liner will be able to move relative to the funnel-shaped portion of the outer shell to massage the surface of the areola.

[0029] The massaging effect applied to the areola can be the same as or different from that applied to the nipple. For example, the massaging effect on the nipple can be achieved through the compression and expansion of the compression section of the liner, which applies force or load approximately perpendicular to the side surface of the nipple to press and pull the side surface. Therefore, the force applied to the surface of the nipple is usually only a single component. Similarly, the inlet end of a breast shield can be arranged such that the liner applies compression and expansion forces to the surface of the areola only at the inlet end, so that the force applied to the surface of the areola is also usually only a single component.

[0030] In various arrangements, the liner can be configured to apply a force having two or more components to the surface of the areola. In these arrangements, the force applied to the surface of the areola can exert compressive force or compressive stress and shear force or shear stress on the surface. Thus, in some forms of the invention, the nipple is subjected only to compressive force or compressive stress, and the areola is subjected to compressive force or compressive stress and shear force or shear stress. In some forms of the invention, there can be three components of force, including compressive force or compressive stress, shear force or shear stress, and lateral force or lateral stress. These components can, for example, be in three dimensions, including radial load, axial load, and lateral load along the X, Y, and Z axes.

[0031] The surface compressive force on the nipple can be achieved by the contraction and expansion (or release or relaxation) of the compression section of the liner against the nipple surface. The cross-section of the compression section can be generally circular such that the contraction and expansion of the compression section against the nipple applies a generally perpendicular force to the nipple. In this respect, during milk expression, a typical nipple will have a generally cylindrical section between the areola and the nipple tip, although it usually has a slight taper from the areola to the nipple tip, such that the contraction of the compression section against the nipple will generally apply a uniform compressive load along the length of the cylindrical section. In other forms of the invention, the cross-section of the compression section can be generally circular, but tapers from a larger diameter to a smaller diameter from the inlet end. This taper will be slight, but can facilitate easy entry of the nipple into the compression section, and given that the nipple usually has the aforementioned slight taper from the areola to the nipple tip, this taper should still apply a uniform load along the side surface of the nipple. The taper of the compression section can also prevent areolar tissue from entering the compression section.

[0032] By adjusting the operating vacuum pressure P inside the outer chamber o As the approximately constant vacuum pressure P1 within the inner chamber decreases, the compression section can contract against the surface of the nipple. This is achieved by reducing the operating vacuum pressure P... o As the vacuum pressure P1 inside the chamber increases, the compression section can expand.

[0033] The constant vacuum pressure P1 in the inner chamber can be from approximately -70 mmHg to -350 mmHg, more preferably from -120 mmHg to -250 mmHg, and even more preferably -200 mmHg. In some embodiments of the invention, the vacuum pressure P1 in the inner chamber is approximately -200 mmHg, and the initial vacuum pressure Pi in the outer chamber is approximately -250 mmHg. In some embodiments of the invention, the operating vacuum pressure P in the outer chamber... o It is set to oscillate between atmospheric pressure and approximately -400 mmHg, which is about twice the constant vacuum pressure inside the Gundam's interior.

[0034] In some forms of the invention, the compression section of the inner chamber can have a natural or relaxed state in which the inner diameter of the compression section is smaller than the outer diameter of the nipple intended for use with the breast shield. This arrangement means that when the breast shield is applied to the mother's breast, the pressure difference applied to the inner and outer chambers causes the compression section to expand to allow nipple insertion. Once inserted, the compression section can return to the natural or relaxed state in which it applies compressive pressure to the nipple. In these forms of the invention, consumers will purchase a breast shield of the appropriate size or a liner of the appropriate size to fit their own nipple size, and the method of the invention will result in an initial vacuum pressure P i The initial vacuum pressure P will be applied to the outer chamber.i Greater than the vacuum pressure inside the chamber. Vacuum pressure P i It can be applied when the inner chamber is at atmospheric pressure, or under vacuum pressure P. i It can be applied when the inner chamber has been evacuated to a roughly constant vacuum pressure P1. In either case, the initial vacuum pressure P... i Both will be greater than the vacuum pressure inside the inner chamber, i.e., more negative than the vacuum pressure inside the inner chamber, causing the compression section of the inner chamber to expand to receive the nipple. Once the nipple is received into the compression section, the operating vacuum pressure P in the outer chamber... o The vacuum pressure P1 in the inner chamber can oscillate to produce a massaging effect on the nipple and areola.

[0035] The advantage of this arrangement is that once the compression section returns to its natural or relaxed state, or its compressed state, the breast shield attaches to the nipple. Then, when vacuum pressure is applied to the inner chamber with the breast shield in proper contact or pressing engagement with the areola, the breast shield remains firmly attached to the breast and in contact with the surfaces of the nipple and areola. Once the pressure differential is then applied to the inner and outer chambers, it produces a beneficial massaging effect on the nipple and areola.

[0036] The compression section of the inner chamber can alternatively have a natural or relaxed state in which the inner diameter of the compression section is larger than the outer diameter of the nipple intended for use with the breast shield. This arrangement means that the nipple can be inserted into the compression section without applying a pressure difference between the inner and outer chambers, allowing, for example, a liner to be placed on the breast before operating the breast shield. In this form of the invention, with the nipple already inserted into the compression section, the compression section is compressed and engaged with the nipple for massage purposes by applying a more positive pressure in the outer chamber than in the inner chamber. For example, for compressing the nipple for massage purposes, if the pressure in the inner chamber is -200 mmHg, the pressure in the outer chamber can oscillate between negative or vacuum pressure and a positive pressure above atmospheric pressure, such as -200 mmHg and atmospheric pressure, or +100 mmHg. At -200 mmHg in both the inner and outer chambers, the inner diameter of the compression section of the liner will be relaxed and thus will be larger than the outer diameter of the nipple, and the nipple will be released from compression. However, when the pressure in the outer chamber increases from -200 mmHg toward atmospheric pressure and exceeds atmospheric pressure, for example, to +100 mmHg, compression will begin.

[0037] The pressure difference applied to the inner and outer chambers can also be operated to produce a massaging effect on the surface of the areola. In some forms of the invention, the massaging effect can be a result of the liner moving forward and away from the areola surface in the region of the inlet end of the breast shield. This forward and away movement can occur while the liner remains attached to or in contact with the areola surface, causing the areola surface to move together with the liner. Although there may also be lateral sliding or frictional movement of the liner relative to or across the areola surface, this movement is not preferred. The preferred movement is a lateral pulling and pushing movement, whereby the vacuum pressure in the inner chamber and the pressure difference applied to the inner and outer chambers can be operated to pull and push against the areola surface, with the liner attached to the areola surface. Sliding movements and combinations of pulling and pushing movements may be present, but again, it is preferred to use only non-sliding or non-frictional movements.

[0038] Therefore, the massaging effect can be generated by a mixture of movements of the liner relative to the areola surface, whether the movement is relative to the areola surface (not preferred) or attached to the areola surface (preferably), and this mixture of movements includes one or more of reciprocating, circumferential or circular, lifting and pressing movements, or a combination of two or more of these types of movements. This movement can be programmed to change during milk expression due to changes in the vacuum pressure values ​​applied to the inner and outer chambers, or due to changes in the oscillation frequency of the vacuum pressure in the outer chamber relative to the vacuum pressure in the inner chamber, or due to a combination of both, or the movement can change naturally during milk expression activities.

[0039] The movement can also vary depending on the physiological function of the breast being expressed, for example, altering between the middle or near end of milking when milking begins when the breast is essentially full and the surface or epidermis of the breast is relatively tense or taut, and when most of the milk has been expressed and the surface or epidermis of the breast is therefore more relaxed or softer. Changes in breast temperature may also affect the movement occurring on or above the areola.

[0040] As indicated above, in some forms of the invention, the movement applied to the areola, and therefore the force applied to the areola, can differ from the movement and force applied to the nipple, in order to apply different massage effects to the areola and nipple. This different application of movement is expected to have a positive effect on the flow of milk through the mammary ducts of the areola and nipple without increasing maternal discomfort; on the contrary, it is expected to increase comfort. This result is both surprising and beneficial.

[0041] Some of the movements generated by the liner abutting the areola surface at the inlet end of the breast shield can be a result of the liner moving inward and outward relative to the outer shell, because the vacuum pressure in the outer chamber oscillates relative to the vacuum pressure in the inner chamber. In some forms of the invention, when the vacuum pressure in the outer chamber is less than that in the inner chamber, the liner can be pulled toward the tip of the nipple, and this movement can occur when the liner contacts the surface of the nipple and / or areola. Therefore, the areola and nipple are further pulled into the outer shell until the vacuum pressure in the outer chamber returns to a vacuum pressure greater than that in the inner chamber, wherein the areola and nipple can move outward relative to the outer shell. This outward movement can be a recovery movement of the areola and nipple from a stretched state to a relaxed state or a more relaxed state.

[0042] In some forms of the invention, the compression section extends to an end section that can collapse at the tip of the nipple (the tip being the end surface of the nipple, typically perpendicular to its length or a side surface) under sufficient pressure differential between the inner and outer chambers. Thus, when the vacuum pressure in the inner chamber is greater than the vacuum pressure in the outer chamber, causing the compression section to apply a compressive or contractile force to the surface of the nipple, the end section can collapse to engage with the tip of the nipple to apply pressure to or on the tip of the nipple. The end section can collapse to engage with the tip of the nipple each time the vacuum pressure in the inner chamber is greater than the vacuum pressure in the outer chamber, such that the end section cyclically engages and disengages from the tip of the nipple. Therefore, the massage effect applied to the breast is applied to each of the areola, the side of the nipple, and the tip or end of the nipple. This pressure can have the same or similar benefits at the tip of the nipple as a massage applied along the length of the nipple and at the areola. Improved milk expression and reduced milk duct blockage are the expected results.

[0043] The lining can collapse in any suitable manner to provide engagement at the nipple tip. In some forms of the invention, the collapse is a three-fold collapse or a star-shaped collapse. In other forms of the invention, the collapse is a two-fold collapse or a bow-shaped collapse.

[0044] To facilitate collapse in the three-fold configuration, the end section can be formed into a triangular polygon shape in either the relaxed or resting state. This polygon shape will form three vertices in the relaxed or resting state, and these vertices will form three creases when the end section collapses. When the end section collapses, three additional inner creases will form between the vertex creases, and these inner creases will converge toward each other and toward the centerline of the lining. The inner creases may converge to a point where they meet and engage, and at this point, the sidewall of the end section closes on and engages with the nipple tip. In this form of the invention, when the vacuum pressure in the outer chamber exceeds the vacuum pressure in the inner chamber, i.e., is more negative, the end section can expand into a circular or round shape within the expansion shape of the lining.

[0045] To facilitate the collapse in the two-fold form, the end segments can be formed with relatively thicker or thinner wall segments in diameter. The collapse will have a bow-shaped end segment formed with two end folds and two inner folds between the end folds. The inner folds can converge to a point where the inner folds meet and join, and at this point, the sidewall of the end segment closes on and joins the nipple tip, while the wall of the inner polygonal segment closes on the nipple.

[0046] The liner can be formed of any suitable material; however, the preferred material is currently silicone / liquid silicone rubber (LSR). The preferred hardness is Shore 40. However, alternatives include: rubber, thermoplastic elastomers (TPE), latex, nitrile rubber (NBR), neoprene rubber, and HCR silicone (thermosetting rubber). A preferred Shore hardness is 20 to 80, more preferably 40 to 60.

[0047] The flexible walls of the liner can have any suitable construction. In some forms of the invention, the walls of the liner have a substantially constant wall thickness. In other forms of the invention, different sections of the liner have substantially constant wall thicknesses. For example, the wall thickness at the inlet end can differ from the wall thicknesses of the compression section and the end section. In other forms of the invention, the wall thickness of the liner can be an irregular thickness or cross-section in one or more sections of the liner. Such irregular thickness or cross-section can be provided to distribute pressure and / or movement unevenly to different sections or areas of the areola and nipple. This can also alter the massaging effect produced on those sections or areas of the areola and nipple.

[0048] Irregular thickness or cross-section can include discrete thick segments formed in the liner wall. For example, four equidistant thick segments can be provided in a liner with otherwise uniform wall thickness. The thick segments can extend longitudinally along the liner, such as one or more segments of the liner, such as compression segments. These thick segments will prevent the liner from expanding circularly, causing the liner to expand in a non-circular shape. This shape can be a generally square expansion shape. Compared to the thick segments, greater expansion will occur in the area between the thick segments of the expanded liner, so that different areas of the areola and nipple will receive different massages or be affected differently under the expansion of the liner. This different treatment means that some areas of the areola and nipple will experience more liner movement and more or less compression or stress than other areas. This different treatment can enhance the massage effect by applying a less uniform and more random distribution of pressure / movement to the areola and nipple.

[0049] The three equidistant thick sections can alternatively be arranged to cause the liner to expand in a roughly triangular shape. Similarly, greater expansion will occur in the region between the thick sections.

[0050] In other forms of the invention, the liner may have a non-uniform wall thickness, the thickness of which gradually increases from a minimum thickness to a maximum thickness relative to the minimum thickness in diameter, and then returns to the minimum thickness. In this form of the invention, greater expansion occurs in the thinner regions of the expansion liner compared to the thicker regions.

[0051] In some forms of the invention, the thicker wall segments can be elongated and thus extend generally in a straight line along the axial direction of the liner, or the thicker wall segments can be formed in a spiral or coiled manner around the liner's axis, or the thicker wall segments can extend along a random, non-uniform path. The thicker wall segments result in some areas of the areola and nipple experiencing more liner movement and more or less compression or stress than other areas. This can enhance the massage effect by applying a less uniform and more random distribution of pressure / movement to the areola and nipple. The thicker wall segments can have a uniform cross-section along the entire length of the segment, or the cross-section of the thicker wall segments can vary along the length, for example, tapering at one end or each end of the segment. In the case of multiple thicker wall segments, the segments can all have the same length or different lengths, and the thickness of the thicker wall segments can also be the same or different.

[0052] The use of long, thicker wall sections can also be combined with the thickness of lining walls that gradually increase from the minimum to the maximum thickness.

[0053] Other portions of the breast shield according to the invention can also be arranged to apply uneven pressure or movement to the areola or nipple. Suitable contours can be formed in the funnel-shaped portion or inlet end of the lining to create recesses or protrusions, such as localized recesses or protrusions. These can include partially spherical protrusions and elongated recesses. Protrusions can form massage points or ridges, while recesses can form suction areas. Protrusions can apply locally increased or concentrated pressure, while recesses can redistribute suction pressure to different areas of the inlet end. This results in localized variations in the movement of the inlet end of the lining against the areola surface, thus affecting the amplitude of the circulatory compression force on the areola. This effect can also guide or move the suction applied to the breast / areola to a larger diameter, increasing the breast shield's holding force on the breast. This increases the safety of the breast shield's attachment to the breast. Attached Figure Description

[0054] To provide a fuller understanding of the invention, some embodiments will now be described with reference to the accompanying drawings, in which:

[0055] Figure 1 A cross-sectional view of a breast shield according to one aspect of the invention is shown.

[0056] Figure 2 This is a schematic diagram of the breast and the forces applied to the areola and nipple by the lining of the breast shield according to the invention.

[0057] Figures 3 to 8 An example of pressure applied to the areola and nipple by a breast shield according to the invention is illustrated.

[0058] Figure 9 An example pressure distribution is shown in the inner and outer chambers of the breast shield according to the present invention.

[0059] Figure 10 The illustration shows the inner lining of a breast shield according to the present invention.

[0060] Figure 11 Is it through Figure 10 The cross section of the lining 11-11 shows three states of collapse and recovery.

[0061] Figure 12 This is a cross-sectional view showing two different configurations of liner collapse.

[0062] Figures 13 to 15 Alternative wall constructions for the lining are shown.

[0063] Figures 16 to 22 This illustrates another alternative wall construction for the lining. Detailed Implementation

[0064] Figure 1A cross-sectional view of a breast shield according to one aspect of the invention is shown. The breast shield 10 has a rigid outer shell 12 and a flexible inner liner 14. The inner liner 14 has a funnel-shaped inlet end 16, and the edge 17 of the inlet end 16 is sealingly engaged with the proximal portion of the outer shell 12. Figure 1 In the diagram, the cross-section of the outer casing 12 is shown as square, but the walls will be circular. The outer casing 12 can be alternatively shaped, and in some forms of the invention, the outer casing 12 has a shape similar to that of the inner liner 14.

[0065] The opposite ends of the outer casing 12 are also sealed together with the inner liner 14, but the sealing structure at the opposite ends is not... Figure 1 As shown in the diagram. This seal can be achieved via an end connection or a manifold, and vacuum pressure can be supplied via the end connection or manifold, and... Figures 3 to 8 The appropriate arrangement is shown in a partial cross-section.

[0066] The inner liner 14 defines an inner chamber 18 for receiving the nipple of a human breast, while an annular outer chamber 20 is defined between the outer shell 12 and the inner liner 14. During use of the breast shield 10, the inner chamber 18 and outer chamber 20 are connected to a vacuum source to evacuate the respective chambers 18 and 20 to below atmospheric pressure. Vacuum lines 22 and 24 communicate with the respective chambers 18 and 20 and extend to a vacuum pump (not shown).

[0067] The outer shell 12 can be used in any suitable shape to connect with the inner liner 14 and form the outer chamber 20 between the outer shell 12 and the inner liner 14.

[0068] The liner 14 has a compression section 26 extending from the inner end of the inlet end 16. The compression section 26 is generally cylindrical, but tapers slightly from a larger diameter at the inlet end 16 to a smaller diameter away from the inlet end 16, and is configured to apply pressure to the nipple inserted into the liner 14. As will be explained later herein, in some forms of the invention, the inner diameter of the compression section 26 is smaller than the outer diameter of the nipple intended for use with a breast shield, such that when the liner 14 is in a relaxed state, the nipple inserted into the compression section 26 is compressed by the liner 14. In other forms of the invention, the compression section 26 may have a natural or relaxed state in which the inner diameter of the compression section is larger than the outer diameter of the nipple intended for use with a breast shield.

[0069] The liner 14 has a collapsible section 28 extending from the inner end of the compression section 26. The collapsible section 28 has a structure that allows its surface to collapse against the tip of the nipple or to close on the surface of the tip of the nipple to apply pressure to the tip of the nipple. This will be discussed later in this document. Figures 11 to 15 discuss.

[0070] In use, the inlet end 16 is positioned against the surface of the breast around the nipple. Therefore, the inlet end 16 is positioned or supported against the surface of the areola of the breast. By positioning the inlet end 16 against the surface of the areola, the nipple of the breast extends into the inner chamber 18 and into the compression section 26 of the liner 14. When the outer diameter of the nipple is smaller than the inner diameter of the compression section 26, the nipple will enter the compression section 26 without resistance. However, when the outer diameter of the nipple is larger than the inner diameter of the compression section 26, the compression section 26 will prevent nipple insertion, and therefore it may be necessary to apply a vacuum to the outer chamber 20 to inflate the compression section 26, thereby allowing the nipple to enter the compression section 26, to avoid having to force the nipple into the compression section 26.

[0071] Considering that the purpose of the invention is to apply a compressive load or force to the nipple during milk extraction, it is considered advantageous to arrange the inner diameter of the compression section 26 to be generally smaller than the outer diameter of the nipple intended to use the liner 14. Therefore, the liner 14 can be arranged to apply compression to the nipple when the liner is relaxed, and this means that less effort is required to apply increased compression to the nipple and the liner 14 can be activated quickly.

[0072] The outer chamber 20 extends from the edge 17 of the inlet end 16 and extends through the compression section 26 and the collapsible section 28. Therefore, applying a pressure difference to the inner chamber 18 and the outer chamber 20 can operate to move the liner 14 from the adjacent edge 17 entirely along the funnel-shaped inlet end 16 and through the compression section 26 and the collapsible section 28. This movement of the liner 14 thus produces a massaging effect on the areola and the nipple, including the nipple tip. Movement occurs in each of the inlet end 16, the compression section 26, and the collapsible section 28, and the movement in each of these portions of the liner 14 differs from the other portions.

[0073] Operating the breast shield 10 involves attaching the breast shield 10 to the breast, with the inlet end 16 seated against the areola of the breast. If the breast shield 10 is in the form of a nipple with an outer diameter smaller than the inner diameter of the compression section 26, the nipple will enter the compression section 26 without resistance, as described above. However, if the outer diameter of the nipple is larger than the inner diameter of the compression section 26, it may be necessary, as a first step, to apply a vacuum to the outer chamber 20 to inflate the liner 14 at the compression section 26, allowing the nipple to enter the compression section 26. This step can be initiated before or after applying a vacuum to the inner chamber 18. If this step is initiated after applying a vacuum to the inner chamber 18, the vacuum required to inflate the compression section 26 in the outer chamber 20 needs to be greater than the vacuum applied to the inner chamber 18.

[0074] Preferably, the vacuum pressure applied to the inner chamber 18 is a substantially constant vacuum, while the vacuum pressure applied to the outer chamber 20 is variable, cycling, oscillating, or pulsating around the vacuum pressure in the inner chamber 18. In some prototype tests, the vacuum pressure within the inner chamber 18 was maintained at approximately -200 mmHg. In these prototype tests, the compression section of the inner chamber 18 was in a natural or relaxed state, in which the inner diameter of the compression section 26 was smaller than the outer diameter of the nipple intended for use with a breast shield, and the outer chamber 20 was set to oscillate between atmospheric pressure and up to approximately -400 mmHg, which is approximately twice the constant vacuum pressure in the inner chamber 18.

[0075] Alternatively, in a natural or relaxed state where the inner diameter of the compression section of the inner chamber is larger than the outer diameter of the nipple intended for use with the breast shield, the vacuum pressure applied to the inner chamber 18 can still be a generally constant vacuum of about -200 mmHg, and the outer chamber 20 can be set to oscillate between a negative pressure value and a positive pressure value, such as a value or point between -200 mmHg and atmospheric pressure, and a positive pressure value such as a value or point between atmospheric pressure and +100 mmHg.

[0076] The outer shell 12 is a rigid shell such that the vacuum pressure within the outer chamber 20 does not cause the outer shell 12 to deform or deflect in any obvious way. Therefore, when the vacuum pressure in the outer chamber 20 oscillates with respect to the vacuum pressure within the inner chamber 18, only the flexible inner liner 14 deforms, deflects, moves, shifts, or vibrates.

[0077] Figure 1 The outline of the breast 30 with the breast shield 10 applied is shown in dashed lines. The areola 32 of the breast 30 sits against the inlet end 16 of the liner 14, while the nipple 34 is within the compression section 26, and although in Figure 1 The compression is not obvious, but the nipple 34 is compressed by the inner wall of the compression section 26. The breast shield 10 is in an inactive state, in which the internal pressure in each of the inner chamber 18 and the outer chamber 20 is atmospheric pressure. Therefore, when a compressive load is applied to the nipple 34, the liner 14 is close to a relaxed state or condition.

[0078] When the breast shield 10 is activated, the vacuum pressure inside the inner chamber 18 is brought to approximately -200 mmHg. This may take several seconds to reach this vacuum. The vacuum pressure inside the outer chamber 20 can be maintained at atmospheric pressure until the inner chamber 18 reaches a predetermined vacuum pressure, or the vacuum pressure inside the outer chamber 20 can also be generated when the inner chamber 18 is evacuated.

[0079] As indicated above, when the breast shield is operated, the vacuum pressure in the outer chamber 20 will oscillate with respect to the constant pressure in the inner chamber 18 to produce the movement required for the liner 14. Figure 2This is a schematic diagram of the load or force applied to the areola 32 and nipple 34 of the breast 30 by the lining 14 of the breast shield 10 during vacuum oscillation of the breast 30 and the vacuum pressure within the outer chamber 20 relative to the constant pressure within the inner chamber 18. The force applied to the areola 32 and nipple 34 is... Figure 2 The arrows indicate that, although the arrows point in only one direction, the force is applied in both the indicated and opposite directions. Therefore, the force can be compressive or tensile.

[0080] exist Figure 2 In this diagram, the force applied to the areola is shown as having both radial and axial compressive components. That is, the force is applied approximately perpendicular to the sloping or curved surface of the areola, and therefore the areola experiences both radial and axial compression. Conversely, the force applied to the nipple is approximately perpendicular to the cylindrical surface, and therefore the force applied to the nipple is a generally radial compressive force. The force applied to the nipple typically has no axial component. Of course, the breasts of lactating mothers undergo significant changes, making... Figure 2 The diagram is understood as a very generalized illustration of the breast and the forces applied to it, but tests conducted to date have shown that despite variations in breast size and shape, the forces applied to the areola and nipple generally remain consistent. Figure 2 The illustration Figure 1 To.

[0081] The force applied to the areola 32 can be described as including compressive force or compressive stress and shear force or shear stress. The combined movement of the inlet end 16 of the liner 14 against the areola 32 involves the two component forces discussed above, such that the inlet end 16 of the liner 14 tends to 1) move on the surface 32 of the areola to produce a massaging effect, or 2) move the outer layer of the breast relative to the inner layer of the breast to produce a massaging effect again, or 3) produce a massaging effect as a combination of both. The movement of the inlet end 16 can be, for example, a reciprocating motion, or a circumferential or circular motion, or a lifting and pressing motion, or a combination of two or more of these types of motion. During milk expression, the movement of the inlet end 16 on or relative to the areola 32 can also vary between these types of motion due to, for example, changes in the value of the vacuum pressure applied in the inner chamber 18 and the outer chamber 20, or due to changes in the oscillation frequency of the vacuum pressure in the outer chamber 20 with respect to the vacuum pressure in the vacuum inner chamber 18, or due to a combination of both.

[0082] The movement of the inlet end 16 on or relative to the areola 32 can also be varied according to the physiological function of the breast being milked, for example, between the beginning of milking when the breast is basically full and the surface or epidermis of the breast is relatively tense or taut, and the middle or near the end of milking when most of the volume of breast milk has been expressed and therefore the surface or epidermis of the breast is more relaxed or softer.

[0083] Importantly, the force applied to the areola 32 differs from the force applied to the nipple 34, thus producing a different massaging effect between the areola 32 and the nipple 34. Tests and experiments have shown that this difference has a positive effect on milk flow through the mammary ducts of the areola 32 and nipple 34 without increasing maternal discomfort; on the contrary, it results in an expected increase in comfort. This result is both surprising and beneficial.

[0084] Figures 3 to 8 An example of the movement of the liner relative to the areola and nipple in a breast shield according to the invention is illustrated. Figures 3 to 8 It shows the location of by Figure 1 The area defined by the dashed line in the diagram is a portion of the lining 40 of the breast shield, such that the shown lining portion 40 is located inside edge 17 and extends into the collapsible section 28. The movement of the lining portion 40 is related to... Figure 9 The pressure distribution shown is related to, Figure 9 The pressure distribution shown is the distribution applied or generated within the inner chamber 18 and outer chamber 20 of the breast shield 10. A constant vacuum is applied within the inner chamber 18, and a variable or pulsating vacuum is applied within the outer chamber 20. Therefore, Figure 9 The Y-axis of the graph represents the increasing vacuum value (i.e., moving upwards to become more negative), while the X-axis represents time. Figure 9 Phases 1 through 6 appeared, and these phases are related to... Figures 3 to 8 It is related to the condition of the inner lining.

[0085] Reference Figure 3 , Figure 3 The initial state of the liner 40 is shown, in which the corresponding pressures in the inner chamber 18 and the outer chamber 20 are at atmospheric pressure. Figure 9 The illustration shows this initial state at stage 1. Dashed line 44 represents the shape of the inner surface 46 of the liner portion 40 under this zero-pressure and isostatic state, and dashed line 44 extends through it. Figures 4 to 8 The inner surface 46 remains unchanged to show the deviation during the application of pressure in the inner chamber 18 and the outer chamber 20.

[0086] from Figure 3 Starting from the initial zero-pressure state, via vacuum line 22 (see...) Figure 1 A vacuum is created in the inner chamber 18 by evacuation, and thus... Figure 4 As shown, the liner portion 40 collapses to form a firm surface engagement or connection with the areola and nipple, which are schematically shown in outline by reference numerals 42 and 43. The liner portion 40 collapses to engage with the side surface of the nipple 43 and also with the end surface or tip of the nipple 43. The constant vacuum generated in the inner chamber 18 is provided by... Figure 9 The "constant vacuum" line is marked and in Figure 9 A constant vacuum is reached at stage 2. Figure 9 At stage 2, the vacuum inside the outer chamber 20 has just begun to be generated.

[0087] exist Figure 5 In the inner chamber 18, a constant vacuum is maintained and is controlled by Figure 9 The pulsating vacuum of the outer chamber 20, indicated by the "pulsating vacuum" line, has increased as shown in stages 2 to 4. Therefore, the pressure difference between the inner chamber 18 and the outer chamber 20 decreases, and as the vacuum pressure within the outer chamber 20 increases, the liner portion 40 tends to pull the areola 42 inward. This can... Figure 5 In the region marked R1, it was observed that the liner portion 40 had been displaced such that the inner surface 46 of the liner portion 40 had moved away from the region indicated by the symbol R1. Figure 3 The dashed line 44 shows the initial shape of the inner surface 46 under atmospheric pressure. As indicated by the lining portion 40 at arrow C1, the nipple 43 remains under compressive load, but the compressive load has been reduced.

[0088] Figure 6 This illustrates the state of the liner 40 when the pulsating vacuum in the outer chamber 20 is at approximately the same vacuum pressure as the constant vacuum in the inner chamber 18. This is achieved by... Figure 9 Phase 4 is indicated. At this phase, the lining portion 40 continues to pull the areola 42 inward (see region R2), while the nipple 43 remains compressed, but... Figure 5 Compared to a state of further compression.

[0089] Figure 7 The state of liner 40 is shown when the fluctuating vacuum is significantly greater than the constant vacuum. This is due to... Figure 9 Phase 5 is indicated. The lining portion 40 continues to pull the areola 42 inward (see region R3), while the compressive load applied to the nipple 43... Figure 6 The compression has been further reduced, effectively releasing nipple 43 from the compressive load. Therefore, nipple 43 is relaxed. The moment when liner 40 releases nipple 43 from compression depends on the pressure difference between inner chamber 18 and outer chamber 20, the construction of liner 40 such as wall thickness, and the flexibility of the material forming liner 40. The materials forming inner liner 14 and thus liner 40 will be discussed later herein.

[0090] exist Figure 8 The peak or maximum fluctuating vacuum is shown, and in the given example, the peak or maximum fluctuating vacuum is approximately twice the constant vacuum generated in inner chamber 20. This is due to... Figure 9Phase 6 is indicated. At phase 6, the lining portion 40 continues to pull the areola 43 inward, while the lining portion 40 now also pulls the nipple 43 inward (see region R4). Importantly, the nipple 43 is no longer subjected to radial compression, but is now in a state of radial expansion.

[0091] Pulsating vacuum Figure 9 After reaching its peak at stage 6, it begins to decrease and follows a sinusoidal path, thus reducing the pulsating vacuum back to atmospheric pressure and then proceeding through the aforementioned... Figures 3 to 9 The described path increases again. As the pulsating vacuum in the outer chamber 20 decreases from its peak or maximum pulsating vacuum, the liner section 40 returns from stage 5 to stage 2. Through these stages, the vacuum in the inner chamber 18 will remain constant. Figure 9 Phase 1 will not be reached because this requires the vacuum within the inner chamber 18 to return to atmospheric pressure. This will only occur when the breast shield 10 is closed. Therefore, as the pulsating vacuum within the outer chamber 20 decreases, the liner portion 40 will push against the areola 42 during the phase described above where it is pulled against the areola 42. Similarly, the liner portion 40 will be released from the pulling load of phase 6 and will pass through the relaxation phase 5 and enter the compression phases 4 through 2. Thus, this cycle applies alternating pulling and pushing loads to the areola 42 and nipple 43. The frequency of this cycle can be in the range of 0.5 Hz to 2 Hz, for example, approximately 1 Hz.

[0092] Figure 1 Lining 14 in Figure 10 Shown separately in [the text]. Figure 10 In the diagram, the cross-sectional shape of the liner 14 (not to scale) is shown at several points between the inlet end 16 and the liner tip 50. It can be observed that the funnel-shaped portion of the inlet end 16 is generally circular, and the compression section 26 is also generally circular. For the reasons discussed above, the compression section 26 does indeed taper slightly from the inlet end 16 toward the liner tip 50. The liner tip 50 includes a polygonal section 52 and a circular tip end 54. The liner tip 50 is designed to collapse on the tip of the nipple inserted into the liner 14 and to apply pressure to the nipple tip during this collapse. This form of collapse is particularly suitable for… Figure 4 It can be observed in, but it can also be found in Figure 5 It was observed that, Figure 5 In the middle, the lining portion 40 is pushed inward against the side surface of the nipple and further inward at the top or tip of the nipple. This collapse is a cyclic collapse, causing the pressure distribution within the inner chamber 18 and the outer chamber 20 to be circulated. Figure 9As shown in the curve cycle, the liner tip 50 repeatedly collapses and recovers. Therefore, the liner tip 50 applies pressure and releases pressure on the nipple tip, which, like the massage action applied to the areola and the lateral surface of the nipple, has been found to provide reduced milk duct blockage and thus improved milk expression.

[0093] The specific construction of the liner 14 provides a three-fold or star-shaped collapse where the liner tip 50 joins the nipple tip. Figure 11 It is a cross-section through the polygonal segment 52 toward the connection with the tip end 54, which shows the three states of the polygonal segment 52 in the cycle of collapse and recovery. Figure 11 The first left image in the image is a polygonal form of segment 52 in a relaxed state within the lining 14. Figure 11 The second intermediate image is when the vacuum in the outer chamber 20 is greater than or equal to the vacuum in the inner chamber 18, for example, in Figure 9 The vacuum curve shows the circular expansion of segment 52 at stages 5 and 6. Figure 11 The third right-hand view shows the vacuum in the inner chamber 18 when it is greater than or equal to the vacuum in the outer chamber 20, for example, in Figure 9 The vacuum curve shows a "three-fold" shape of collapse in segment 52 at stages 2 and 3.

[0094] When the polygonal segment 52 collapses, the circular tip 54 also collapses. However, since it is the polygonal segment 52 that collapses to join the nipple tip, the form of collapse of the tip 54 is not particularly important.

[0095] The collapse of section 52 also exhibits a "three-fold" shape. Figure 12 As shown in the figure, but the figure also shows an alternative collapsible shape for segment 52 that is different from the three-fold shape. Figure 12 The views in the diagram are cross-sectional views through the polygonal segment 52 toward the compressed segment 26, and these views are two different liner portions, the first liner portion being the liner portion 50 showing the partially collapsed segment 52. Figure 11 The three creases 56 are clearly visible, but as these creases are formed, the inner creases 58 are also formed to converge toward each other and toward the center lines of the lining tip 50 and the inner lining 14. The inner creases 58 may converge to the point where the inner creases 58 meet and join, and at this point the wall of the polygonal segment 52 of the inner lining 14 closes on the nipple tip and joins with the nipple tip.

[0096] Figure 12The second lining tip 60 is folded into a "bow" shape and has four folds, namely two end folds 62 and two middle folds 64. Similarly, the middle folds 64 can converge to the point where the middle folds meet and join, and at this point the wall of the polygonal segment 52 of the lining 14 has closed on the nipple tip and joined with the nipple tip.

[0097] Figure 12 The illustration shows that the liner tip can be shaped in different ways but still collapses in the desired manner to join with the nipple tip.

[0098] The lining 14 can be formed of any suitable material, such as those listed earlier in this document.

[0099] Figures 13 to 15 Alternative wall constructions for the flexible walls used in the liner are shown. While the walls of the liner can have a constant thickness like liner 14, they can also have irregular thicknesses or cross-sections to unevenly distribute pressure and / or movement to different segments or areas of the areola and nipple. This can also alter the massaging effect produced on these segments or areas of the areola and nipple. Figures 13 to 15 Each of the examples shows a liner with a compression section, which is typically circular but has an irregular cross-section. As discussed below, all liners are inflated to apply uneven pressure or movement relative to the surface of the areola and / or nipple in contact with the liner.

[0100] Figure 13 The liner 70 is shown to have four equidistant thick sections 72. These sections 72 may be short, discrete sections formed in specific portions of the liner, or they may be longer sections extending completely through one or more sections of the liner. For example, sections 72 may be provided only in compression sections of the liner, but sections 72 may extend through the entire length of the compression section, or through a portion of the compression section. Sections 72 may extend in a straight line generally along the axis of the liner, or sections 72 may be formed in a helical or spiral manner around the axis of the liner.

[0101] Section 72 prevents the circular expansion of liner 70, resulting in non-circular expansion or, in this case, roughly square expansion. The size of the arrows in the expansion image of liner 70 indicates the level of movement of liner 70 under expansion and shows that greater expansion occurs in the corner areas of the expanded liner 70 compared to the area of ​​the thick section 72, causing different areas of the areola and nipple to receive different massages or be affected differently under liner expansion. This different treatment means that some areas of the areola and nipple will experience more liner movement and more or less compression or stress than other areas. This different treatment can enhance the massage effect by applying a less uniform and more random distribution of pressure / movement to the areola and nipple.

[0102] Figure 14 A liner 74 is shown having three equidistantly spaced thick sections 76, which prevent circular expansion of the liner 74 from causing non-circular expansion, and... Figure 14 A roughly triangular expansion occurs in the middle. However, again, a greater expansion occurs in the corner region of the expanding liner 74 compared to the region of the thick section 76.

[0103] Figure 15 A liner 78 with a non-uniform wall thickness is shown, the thickness of which gradually increases from a minimum thickness at region 80 to a maximum thickness at region 82, which is diametrically opposite to region 80, and then returns to a minimum thickness at region 80. Figure 15 and Figure 13 and Figure 14 The difference lies in the fact that the maximum and minimum movements of the liner occur in the diametrically opposite regions of the liner 78, and the changes in movement gradually increase and decrease between the opposite regions 80 and 82. Greater expansion occurs in the thinner regions of the expanding liner 78 compared to the thicker regions.

[0104] Figure 16 The compression section 92 applied to the liner 90, and particularly to the liner 90, is shown. Figure 14 The arrangement. It can be observed that... Figure 14 The thick section 76 is formed as an elongated spiral ridge extending over the entire length or height of the compressed section 92. It can be observed that the ridge 76 tapers at the opposite ends, and this can be easily seen in the cross section BB, which is different from CC.

[0105] Figure 17 It shows Figure 16 An alternative arrangement is provided, wherein the liner 94 includes a compression section 96 having an increased number of thick sections or ridges 98. The ridges 98 are aligned with... Figure 16The ridges 76 are formed in the same spiral manner and taper at the opposite ends of the ridges 98. Each ridge 98 extends over the entire height or length of the compressed section 96.

[0106] Figure 18 Another alternative arrangement is illustrated, wherein the liner 100 has a compression section 102 comprising a plurality of thick sections or ridges 104, but not all of the ridges 104 extend over the entire height or length of the compression section 102. Figure 18 As shown, the ridge 106 terminates within the compression section 102.

[0107] at last, Figure 19 and Figure 20 The wall thickness image of the compression section is shown. Figure 15 The changes are as shown, but the compression section also includes... Figure 14 The thick section provided is similar to the thick section in the text. Therefore, Figure 19 A liner 104 with a compression section 106 is shown, the compression section 106 having three thick sections or elongated ridges 108. The ridges 108 are formed in a manner similar to... Figure 16 The ridge of the lining 90 is 76, but the ridge 108 has been applied to have a ridge in Figure 15 The liner is of the type with uneven wall thickness shown in liner 78. Figure 20 The basic fusion of the construction of liners 74 and 78 is shown to obtain the compression section 106 of liner 104.

[0108] Figures 13 to 20 The examples given illustrate how the liner construction can be used to influence the way the liner responds to the pressure difference applied to the inner chamber 18 and the outer chamber 20, and thus affect how the liner applies pressure to the areola and nipple and moves against the areola and nipple.

[0109] Other parts of the breast shield according to the invention may also be arranged to apply uneven pressure or movement to the areola or nipple. Figure 21 and Figure 22 The outline of the funnel-shaped portion or inlet end of the liner to form a partial recess or protrusion is shown. The liner 110 has an inlet end 112, which is formed in a funnel shape like the inlet end 16 of the liner 14 in the previous figure, and the inlet end 112 includes a partially spherical protrusion 114 and an elongated recess 116.

[0110] The protrusion 114 forms a massage point or ridge, while the recess 116 forms a suction area. The protrusion 114 can apply locally increased or concentrated pressure, while the recess 116 can redistribute suction pressure to different areas of the inlet end 112. This results in localized variations in the movement of the inlet end 112 of the liner 110 against the areola surface, thus affecting the amplitude of the circulatory compression force on the areola. This effect can also guide or move the suction applied to the breast / areola to a larger diameter to increase the retention force of the breast shield on the breast. This increases the security of the breast shield attachment to the breast.

[0111] The movement of the lining, described and illustrated in the accompanying drawings, applies pressure to the areola and nipple as the pressure in the outer chamber of the breast shield circulates with respect to the constant pressure in the inner chamber. This movement produces a massaging effect on the tissue surfaces of the areola and nipple. Figure 2 As shown, it is precisely this difference in effect that produces the surprising and beneficial effects described in this article.

[0112] Where any or all of the terms “comprising” or similar terms are used in this application document (including the claims), such terms shall be interpreted as specifying the presence of the stated feature, integral, step or component, but not excluding the presence of one or more other features, integrals, steps or components.

[0113] Those skilled in the art will recognize that the invention described herein can be modified and altered in many ways, in addition to those specifically described. It should be understood that the invention includes all such modifications and alterations falling within the spirit and scope of the invention.

[0114] Future patent applications may be filed in Australia or overseas based on this application or claiming priority to this application. It should be understood that the appended provisional claims are provided by way of example only and are not intended to limit the scope of protection claimed in any such future application. Features may be added to or removed from the provisional claims later to further define or redefine one or more inventions.

Claims

1. A breast pump for expressing human breast milk, wherein the breast pump comprises an outer shell and a flexible inner liner located within the outer shell, wherein, In use, when the breast shield is applied to the breast, the liner contacts the surfaces of both the areola and the nipple of the breast. The breast shield also includes an outer chamber located between the outer shell and the liner, and an inner chamber located within the liner. In use, the inner chamber and the outer chamber are able to withstand a pressure difference, and the pressure difference is operable to cause the liner to apply a massaging effect to the surfaces of both the areola and the nipple of the breast. The massaging effect on the areola and the nipple is a result of the liner moving inward and outward within the outer shell and relative to the outer shell as the vacuum pressure in the outer chamber oscillates with respect to the vacuum pressure in the inner chamber.

2. The breast shield of claim 1, comprising an inlet end, wherein in use, the inlet end abuts against the surface of the areola of the breast and applies a massage effect to the areola, the outer shell and the inner liner both extend to the inlet end, and the outer chamber extends at the inlet end between the inner liner and the outer shell.

3. The breast shield according to claim 1, wherein the massage effect applied to the areola is different from the massage effect applied to the nipple.

4. A breast pump for expressing human breast milk, the breast pump comprising: A rigid outer shell and a flexible inner liner located within the outer shell. The liner defines an inner chamber and an annular outer chamber, the inner chamber being for receiving the nipple of a human breast, and the outer chamber being defined between the outer shell and the liner. The inner and outer chambers are capable of withstanding pressure differentials. The breast shield has an inlet end that, in use, abuts against the surface support of the areola of the breast. The outer shell and the inner liner extend to the inlet end such that, in use, the inner liner abuts against the surface support of the areola around the nipple. The liner has a compression section located inside the inlet end for receiving the nipple. In use, applying a pressure difference between the inner chamber and the outer chamber can operate such that: the liner moves relative to the outer shell at the inlet end to massage the surface of the areola; and the compression section of the liner expands and contracts relative to the inserted nipple to massage the surface of the nipple. The massaging effect on the areola and the nipple is a result of the inner liner moving inward and outward relative to the outer shell as the vacuum pressure in the outer chamber oscillates with respect to the vacuum pressure in the inner chamber.

5. The breast shield of claim 4, wherein the inlet end has a generally conical or funnel-shaped portion, the generally conical or funnel-shaped portion comprising complementary funnel-shaped portions of the liner and the outer shell, wherein the funnel-shaped portion of the liner is configured to provide a surface support engagement against the areola, and the funnel-shaped portion of the liner is movable relative to the funnel-shaped portion of the outer shell for massaging the surface of the areola.

6. The breast shield according to claim 4, wherein the massage effect on the nipple is achieved by compression and expansion of the compression section of the liner, the compression and expansion being substantially perpendicular to the side surface of the nipple to press and pull the side surface.

7. The breast shield according to claim 4, wherein the massaging effect on the areola is achieved by compression and expansion of the lining at the inlet end, the compression and expansion applying compressive force or compressive stress and shear force or shear stress to the surface of the areola.

8. The breast shield according to claim 4, wherein the compression section has a natural or relaxed state, wherein in the natural or relaxed state, the inner diameter of the compression section is smaller than the outer diameter of the nipple intended for use with the breast shield.

9. The breast shield according to claim 4, wherein the massaging effect on the areola is the result of the following movements of the lining in the region of the inlet end of the breast shield: movement in a forward direction away from the surface of the areola, or lateral movement relative to the surface of the areola, or by reciprocating movement, or by circumferential or circular movement, or by lifting and pressing movement, or a combination of two or more of these types of movements.

10. The breast shield according to claim 4, wherein the compression section extends to an end section capable of collapsing on the tip of the nipple.

11. The breast shield according to claim 10, wherein the end section is capable of collapsing into a three-fold collapse or a two-fold collapse.

12. The breast shield according to claim 10, wherein the end portion is formed to have a triangular polygonal shape in a relaxed or static state.

13. The breast shield according to claim 4, wherein the wall of the lining has an irregular thickness or cross-section in one or more sections of the lining.

14. The breast shield of claim 4, wherein the wall of the lining has an irregular thickness or cross-section in one or more sections of the lining, and thus the wall of the lining has discrete thick sections formed in the lining wall, wherein, The thick section is elongated and extends in a straight line generally along the axis of the liner, or the thick section is formed in a generally spiral or coiled manner around the axis of the liner, or in a random manner.

15. The breast shield according to claim 4, wherein the liner is formed at the inlet end with a recess and / or a protrusion, the recess and / or the protrusion being operable to apply locally increased or concentrated pressure.

16. A method for operating a breast pump unit for expressing human breast milk using a breast pump according to any one of claims 1 to 15, the method comprising: Apply the breast shield to the breast; A substantially constant vacuum pressure P1 is applied to the inner chamber; And a vacuum pressure is applied in the outer chamber with respect to the oscillation of the vacuum pressure in the inner chamber, such that: a. The compression section of the inner chamber expands and contracts relative to the nipple inserted into the compression section, and b. The liner moves relative to the outer shell at the entrance end to provide a massaging effect on the surface of the areola.

17. The method according to claim 16, wherein the vacuum pressure in the inner chamber is from -70 mmHg to -350 mmHg.

18. The method according to claim 16 or 17, wherein the vacuum pressure in the outer chamber oscillates between atmospheric pressure and approximately twice the vacuum pressure in the inner chamber.

19. The method according to any one of claims 16 to 18, the method comprising applying an initial vacuum pressure P to the outer chamber that is greater than the vacuum pressure P1 of the inner chamber. i This causes the compression section of the inner chamber to expand to receive the nipple, and then the vacuum pressure in the outer chamber is adjusted so that the operating vacuum pressure P in the outer chamber is... o The vacuum pressure P1 in the inner chamber oscillates.

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